Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes
Purpose
The aim of this project is to investigate the effects of riboflavin, also known as vitamin B2, on preventing delayed onset muscle soreness (DOMS) in ultramarathon athletes through a randomized placebo-controlled study.
Condition
- Muscle Soreness
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 or over 4. In good general health as evidenced by readiness to participate in an ultramarathon 5. Ability to take oral medication and be willing to adhere to the study regimen 6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening.
Exclusion Criteria
- Unable to read or understand English 2. Under 18 years of age 3. Pregnancy or lactation 4. Known allergic reactions to components of the investigational drugs
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- A phase I randomized, 2 arm single blinded feasibility study
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
- Masking Description
- Subjects will be masked to which intervention they receive, active study drug or placebo.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Riboflavin Group |
Riboflavin 100mg will be self administered by participants, one capsules prior to the long stage of the race followed by a second dose at the completion of the long stage. |
|
|
Placebo Comparator Placebo/Control Group |
Placebo will be self administered by participants, one capsule prior to the long stage of the race followed by a second dose at the completion of the long stage. |
|
Recruiting Locations
The University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- Steven Moore
Detailed Description
The riboflavin 100 mg capsules will be self-dosed by the participant, one capsule prior to the long stage of the race followed by a second dose at the end of the long stage. Historically, long-stage finish times have ranged between 8 and 24 hours. The placebo will also be dosed as one capsule on the morning of the long stage, prior to the race start, and one capsule at the end of the long stage.